The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Ethicon Ets Endoscopic Linear Cutters.
| Device ID | K070859 |
| 510k Number | K070859 |
| Device Name: | REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS |
| Classification | Staple, Implantable, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Minneapolis, MN 55369 |
| Contact | Caroline Butterfield |
| Correspondent | Caroline Butterfield STERILMED, INC. 11400 73RD AVE. NORTH Minneapolis, MN 55369 |
| Product Code | NLL |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-28 |
| Decision Date | 2007-09-12 |
| Summary: | summary |